Study Stopped
The study could not be performed as planned for organizational reasons.
Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AD03 Applied During AFF005A
Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD03 Applied During AFFiRiS 005A
1 other identifier
observational
16
1 country
2
Brief Summary
This is a phase Ib follow-up study to evaluate long-term safety and tolerability of immunization with AFFITOPE AD03 applied during AFFiRiS 005A.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 16, 2011
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedNovember 6, 2013
November 1, 2013
1.5 years
December 16, 2011
November 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Safety/Tolerability
* Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal * Number and kind (description) of AEs * Number and kind (description) of SAEs * Changes from study AFF005A in: Physical and neurological examination/ Concomitant medication/ Vital signs (blood pressure, heart rate, respiratory rate, body temperature)/ Body mass (weight)/ MRI of the brain/ ECG/ Laboratory assessment (haematology, biochemistry, coagulation, serology, APP crossreactivity and urinalysis)
52 weeks
Secondary Outcomes (2)
Clinical Efficacy
52 weeks
Immunological
52 weeks
Study Arms (2)
AFFITOPE AD03 with adjuvant
AFFITOPE AD03 without adjuvant
Eligibility Criteria
Patients with mild to moderate Alzheimer's disease (MMSE 16 to 26)that have participated in AFF005A
You may qualify if:
- Written informed consent signed and dated by the patient and the caregiver.
- Patients having participated in AFFiRiS 005A and received ≥1 vaccination with AFFITOPE AD03
- Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits and being available for the telephone phone calls
You may not qualify if:
- Patients having received no vaccination with AFFITOPE AD03
- History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Affiris AGlead
Study Sites (2)
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt
Vienna, 1080, Austria
Medical University of Vienna, Department for Psychiatry and Psychotherapy
Vienna, 1090, Austria
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siegfried Kasper, Prof.Dr.
Medical University of Vienna ,Department for Psychiatry and Psychotherapy
- PRINCIPAL INVESTIGATOR
Dieter Volc, Prim. Dr.
Studienzentrum der PROSENEX,AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2011
First Posted
April 2, 2012
Study Start
December 1, 2011
Primary Completion
June 1, 2013
Study Completion
October 1, 2013
Last Updated
November 6, 2013
Record last verified: 2013-11